Events

Retiro De Equipo (Recall) de BROSELOW/HINKLE PEDIATRIC EMERGENCY SYSTEM KIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por TRUDELL MEDICAL MARKETING LIMITED.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    141691
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-07-16
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    The broselow/hinkle intraosseus module which is part of the broselow/hinkle pediatric emergency system contains a 15g intraosseus needle that is not compatible with the iv extension set that is provided in the module. this may result in a leak at the connection and delay treatment.

Device

BROSELOW/HINKLE PEDIATRIC EMERGENCY SYSTEM KIT
  • Modelo / Serial
    Model Catalog: 7730PUR5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730RED5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730ORG5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730MOD (Lot serial: 001K to 149K inclusive); Model Catalog: 7730IALS (Lot serial: 001K to 149K inclusive); Model Catalog: 7730GRN5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730BLU5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730ALS (Lot serial: 001K to 149K inclusive); Model Catalog: 7730YEL5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730WHI5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730RED5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730PUR5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730ORG5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730MOD (Lot serial: 245F to 366F inclusive); Model Catalog: 7730IALS (Lot serial: 245F to 366F inclusive); Model Catalog: 7730GRN5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730BLU5 (Lot seria
  • Descripción del producto
    BROSELOW/HINKLE PEDIATRIC SYSTEM KIT
  • Manufacturer
    TRUDELL MEDICAL MARKETING LIMITED

Manufacturer

TRUDELL MEDICAL MARKETING LIMITED